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Roche Holding AG

Drug Names(s): GDC-0449, Systemic Hedgehog Antagonist, RG3616, Vismodegib

Description: The Systemic Hedgehog Antagonist inhibits the Hedgehog Signaling Pathway, which is involved in signaling certain adjacent cells within the tumor environment to produce various growth and angiogeneic (blood vessel) forming factors that can positively influence tumor maintenance and growth.

RG3616 is a small-molecule inhibitor designed to specifically inhibit SMO. In preclinical models, RG3616 inhibits overactive SMO signaling and tumorgrowth driven by mutations or by elevated levels of Hh ligands, offering the potential for broadapplication. Inhibition of SMO signaling renders the transcription factor GLI inactive,preventing the expression of genes that mediate the role of Hh on tumor growth.

Deal Structure: In June 2003, Curis established a collaboration with Genentech that included continued development of its systemically administered Hedgehog antagonist drug candidates for the treatment of cancer. Under the terms of the agreement, Curis granted Genentech an exclusive, royalty-bearing license, with the right to sublicense, to make, use, sell and import, small molecule and antibody inhibitors of the Hedgehog signaling pathway, for applications in cancer therapy. Curis had responsibilities to perform certain funded preclinical research activities and, to the extent relevant, co-fund clinical development costs for certain products. Genentech has primary responsibility for clinical development, regulatory affairs, manufacturing and supply, formulation and sales and marketing.

Curis announced on September 1, 2006 that pursuant to the terms of its 2003 collaboration agreement with Genentech it has elected to cease its participation in the co-development of the See full deal structure in Biomedtracker

Partners: Curis, Inc. Chugai Pharmaceutical Co., Ltd.

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